US FDA Ready To Accept 510(k) Devices To Expedited Access/Breakthrough Pathway
Manufacturers considering the Expedited Access Pathway for 510(k) devices should start the submission process, experts and agency staff say, although it still remains to be seen what types of 510(k) devices will qualify. The December-enacted 21st Century Cures Act added 510(k) devices to the program as part of its Breakthrough Device provision.
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Pear Therapeutics announced US Expedited Access Pathway designation earlier this month for its 510(k)-route reSET-O Prescription Digital Therapeutic for OUD, perhaps providing some insight into the types of products seeking a "substantial equivalence" claim that might, nonetheless, be considered breakthroughs.
The Breakthrough Devices Program is the established Expedited Access Pathway with some statutory updates, including the addition of 510(k)-pathway devices. But FDA also uses the congressionally-mandated draft guidelines to outline some new features in the program that are not in the statute, including a process for "breakthrough device sprint discussions."
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.